Aripiprazole Sandoz

Package Leaflet: Information for the Patient

Aripiprazole Sandoz, 10 mg, Orally Disintegrating Tablets

Aripiprazole Sandoz, 15 mg, Orally Disintegrating Tablets

Aripiprazole Sandoz, 30 mg, Orally Disintegrating Tablets

Aripiprazolum

Read the Package Leaflet Carefully Before Taking the Medication, as it Contains Important Information for the Patient.

• Keep this package leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medication has been prescribed for your current condition. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this package leaflet, inform your doctor or pharmacist. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Aripiprazole Sandoz and What is it Used For
• 2. Important Information Before Taking Aripiprazole Sandoz
• 3. How to Take Aripiprazole Sandoz
• 4. Possible Side Effects
• 5. How to Store Aripiprazole Sandoz
• 6. Package Contents and Other Information

1. What is Aripiprazole Sandoz and What is it Used For

Aripiprazole Sandoz contains the active substance aripiprazole and belongs to a group of medications called antipsychotics. It is used in adults and adolescents aged 15 years and older to treat a disease characterized by symptoms such as hearing, seeing, and feeling non-existent things, suspiciousness, delusions, chaotic speech and behavior, and emotional flattening. Patients with this disease may also experience sadness, anxiety, or tension and have a sense of guilt. Aripiprazole Sandoz is used in adults and adolescents aged 13 years and older to treat a disease with symptoms such as strong excitement, excessive energy, less need for sleep than usual, very rapid speech with racing thoughts, and sometimes severe irritability. It also prevents the recurrence of these symptoms in adult patients who have responded to previous treatment with orally disintegrating tablets of Aripiprazole Sandoz.

2. Important Information Before Taking Aripiprazole Sandoz

When Not to Take Aripiprazole Sandoz

If you are allergic to aripiprazole or any of the other ingredients of this medication (listed in section 6).

Warnings and Precautions

Before starting treatment with Aripiprazole Sandoz, discuss it with your doctor. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience thoughts or feelings of self-harm. Before starting treatment with Aripiprazole Sandoz, inform your doctor if you have: high blood sugar levels (characterized by excessive thirst, urination, increased appetite, and weakness) or a family history of diabetes; seizures (epilepsy), as this may indicate that your doctor wants to monitor you closely; involuntary, irregular muscle movements, especially of the face; cardiovascular diseases (heart and circulation diseases), a history of cardiovascular disease, stroke, or "mini" stroke, abnormal blood pressure; blood clots or a history of blood clots in your family, as the use of antipsychotic medications is associated with the formation of blood clots; a history of gambling addiction. If you experience increased weight, unusual movements, drowsiness that interferes with daily activities, difficulty swallowing, or signs of an allergic reaction, you should inform your doctor. If you are an elderly patient with dementia (loss of memory and other mental abilities) who has had a stroke or "mini" stroke, you or your caregiver or relative should inform your doctor. If you experience thoughts or feelings of self-harm, you should immediately inform your doctor. During treatment with aripiprazole, thoughts and behaviors of suicide have been reported. You should immediately inform your doctor if you experience stiffness of the muscles or stiffness with high fever, sweating, mental disorders, or very rapid or irregular heartbeat. If you or your family or caregiver notice that you start to feel the urge or desire to behave in an unusual way and cannot resist the impulse, urge, or temptation to engage in activities that may harm you or others, you should tell your doctor. These phenomena are called impulse control disorders and may manifest as behaviors such as compulsive gambling, overeating, or excessive spending, excessive sexual drive, or increased frequency and intensity of sexual thoughts or feelings. Your doctor may consider it necessary to change the dose or discontinue the medication. Aripiprazole may cause drowsiness, decreased blood pressure when standing up, dizziness, and changes in mobility and balance, which can lead to falls. You should be careful, especially if you are an elderly or weakened patient.

Children and Adolescents

Aripiprazole Sandoz should not be used in children and adolescents under 13 years of age. It is not known whether the use of this medication is safe and effective in these patients.

Aripiprazole Sandoz and Other Medications

Tell your doctor or pharmacist about all medications you are currently taking or have recently taken, as well as any medications you plan to take, including those available without a prescription. Blood pressure-lowering medications: Aripiprazole Sandoz may enhance the effect of blood pressure-lowering medications. If you are taking blood pressure-lowering medications, you should inform your doctor. Taking Aripiprazole Sandoz with certain medications may require your doctor to change the dose of Aripiprazole Sandoz or other medications you are taking. It is especially important to inform your doctor about the use of the following medications: medications used to treat heart rhythm disorders (such as quinidine, amiodarone, flecainide); antidepressant medications or herbal products used to treat depression and anxiety (such as fluoxetine, paroxetine, venlafaxine, St. John's wort); antifungal medications (such as ketoconazole, itraconazole); certain medications used to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors, e.g., indinavir, ritonavir); antiepileptic medications used to treat epilepsy (such as carbamazepine, phenytoin, phenobarbital); certain antibiotics used to treat tuberculosis (rifabutin, rifampicin). These medications may increase the risk of side effects or decrease the effect of Aripiprazole Sandoz. If you experience any unusual symptoms while taking these medications with Aripiprazole Sandoz, you should inform your doctor. Medications that increase serotonin levels are usually used to treat diseases including depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain: tryptans, tramadol, tryptophan used to treat such diseases as depression, generalized anxiety disorder, obsessive-compulsive disorder (OCD), and social phobia, as well as migraine and pain; selective serotonin reuptake inhibitors (SSRIs) (such as paroxetine and fluoxetine) used to treat depression, OCD, panic attacks, and anxiety; other antidepressant medications (such as venlafaxine and tryptophan) used to treat severe depression; tricyclic antidepressant medications (such as clomipramine and amitriptyline) used to treat depression; St. John's wort (Hypericum perforatum) used as a herbal preparation for mild depression; painkillers (such as tramadol and pethidine) used to relieve pain; tryptans (such as sumatriptan and zolmitriptan) used to treat migraine. These medications may increase the risk of side effects. If you experience any unusual symptoms while taking these medications with Aripiprazole Sandoz, you should inform your doctor.

Aripiprazole Sandoz with Food, Drink, and Alcohol

This medication can be taken with or without food. You should avoid drinking alcohol.

Pregnancy, Breastfeeding, and Fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, ask your doctor for advice before taking this medication. In newborns whose mothers took aripiprazole during the last trimester (last 3 months) of pregnancy, the following symptoms may occur: tremors, muscle stiffness, and (or) weakness, drowsiness, agitation, breathing difficulties, and feeding difficulties. If you notice any of these symptoms in your child, you should contact your doctor. If you are taking Aripiprazole Sandoz, your doctor will discuss with you whether you should breastfeed, considering the benefits of treatment and the benefits of breastfeeding. You should not take this medication and breastfeed. If you are taking this medication, you should discuss with your doctor the best methods for feeding your child.

Driving and Using Machines

While taking this medication, dizziness and vision disturbances (see section 4) may occur. You should take this into account when performing tasks that require full attention, such as driving or operating machinery.

Aripiprazole Sandoz Contains Lactose, Sodium, Aspartame, and Benzyl Alcohol

If you have been diagnosed with an intolerance to some sugars, you should contact your doctor before taking this medication. This medication contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, which means it is considered "sodium-free". 10 mg tablets:This medication contains 1.0 mg of aspartame in each orally disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. This medication contains up to 0.0036 mg of benzyl alcohol in each orally disintegrating tablet. Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease should contact their doctor before taking this medication, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). 15 mg tablets:This medication contains 1.5 mg of aspartame in each orally disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. This medication contains up to 0.0054 mg of benzyl alcohol in each orally disintegrating tablet. Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease should contact their doctor before taking this medication, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis). 30 mg tablets:This medication contains 3.0 mg of aspartame in each orally disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its improper excretion. This medication contains up to 0.0108 mg of benzyl alcohol in each orally disintegrating tablet. Benzyl alcohol may cause allergic reactions. Patients with liver or kidney disease should contact their doctor before taking this medication, as a large amount of benzyl alcohol may accumulate in their body and cause side effects (so-called metabolic acidosis).

3. How to Take Aripiprazole Sandoz

This medication should always be taken exactly as prescribed by your doctor or pharmacist. If you are unsure, ask your doctor or pharmacist. The recommended dose for adults is 15 mg once a day.However, your doctor may prescribe a lower or higher dose, up to a maximum of 30 mg once a day.

Use in Children and Adolescents

Your doctor may recommend starting treatment with a low dose given in liquid form (oral solution). This dose can be gradually increased to the recommended dose for adolescents, which is 10 mg once a day. However, your doctor may also prescribe a lower or higher dose, up to a maximum of 30 mg once a day. If you feel that the effect of Aripiprazole Sandoz is too strong or too weak, you should consult your doctor or pharmacist.

You Should Try to Take Aripiprazole Sandoz at the Same Time Every Day.

It does not matter whether you take the orally disintegrating tablet with or without food. The blister should be opened directly before taking the medication. To expose and remove one tablet, you should open the packaging, separate a single blister fragment, and pull its top part. You should not push the tablet through the foil, as this may damage the tablet. Immediately after opening the blister, you should remove the tablet with dry fingers and place it on your tongue. The tablet dissolves quickly in saliva. You can swallow it with or without liquid. Another way to take the tablet is to mix it with water and drink the resulting suspension. Even if you feel better,you should not change the dose or stop taking Aripiprazole Sandoz without first discussing it with your doctor.

Taking More Than the Recommended Dose of Aripiprazole Sandoz

If you take more of Aripiprazole Sandoz than your doctor prescribed (or if someone else takes some of the medication not intended for them), you should immediately contact your doctor. If you have difficulty contacting your doctor, you should go to the nearest hospital, taking the medication packaging with you. In patients who have taken too much aripiprazole, the following symptoms have occurred: rapid heartbeat, agitation/aggression, speech problems; unusual movements (especially of the face or tongue) and decreased consciousness; other symptoms may include: acute confusion, seizures (epilepsy), coma, a combination of fever, rapid breathing, excessive sweating; muscle stiffness and sluggishness or drowsiness, slow breathing, choking, high or low blood pressure, irregular heartbeat. If you experience any of these symptoms, you should immediately contact your doctor or hospital.

Missing a Dose of Aripiprazole Sandoz

If you miss a dose of Aripiprazole Sandoz, you should take it as soon as you remember. You should not take two doses in one day.

Stopping Treatment with Aripiprazole Sandoz

You should not stop treatment, even if you feel better. It is very important to take the medication for as long as your doctor has prescribed. If you have any further questions about taking this medication, you should ask your doctor or pharmacist.

4. Possible Side Effects

Like all medications, Aripiprazole Sandoz can cause side effects, although not everybody gets them. Common side effects (may affect up to 1 in 10 people): diabetes, sleep disturbances, anxiety, restlessness and inability to sit or stand still, akathisia (uncontrollable feeling of inner restlessness and an urgent need to be in constant motion), uncontrollable trembling, jerky movements or writhing movements, tremors, headache, fatigue, drowsiness, dizziness, blurred vision, decreased number of bowel movements or difficulty with bowel movements, constipation, nausea, vomiting, increased salivation, vomiting, feeling of tiredness. Uncommon side effects (may affect up to 1 in 100 people): increased prolactin levels in the blood, high blood sugar levels, depression, changed or increased interest in sex, uncontrollable movements of the muscles of the mouth, tongue, and limbs (tardive dyskinesia), muscle disorders causing twisting movements (dystonia), restless legs syndrome, double vision, increased sensitivity of the eyes to light, rapid heartbeat, decreased blood pressure when standing up, which can cause dizziness, dizziness, or fainting, hiccups. The following side effects have been reported after the introduction of aripiprazole in oral form to the market, but their frequency is not known: decreased number of white blood cells, decreased number of platelets, allergic reaction (e.g., swelling of the mucous membranes of the mouth, tongue, face, and throat, itching, hives), onset of diabetes or worsening of its course, ketoacidosis (presence of ketone bodies in the blood and urine) or diabetic coma, high blood sugar levels, low sodium levels in the blood, loss of appetite (anorexia), weight loss, weight gain, suicidal thoughts, suicide attempts, and completed suicides, feelings of aggression, agitation, nervousness, simultaneous occurrence of fever, muscle stiffness, rapid breathing, sweating, and changes in mental status and sudden changes in blood pressure and heart rate, fainting (malignant neuroleptic syndrome), seizures (epilepsy), serotonin syndrome (a reaction that can cause a feeling of great happiness, drowsiness, clumsiness, restlessness, especially motor, feeling of intoxication, sweating, or muscle stiffness), speech disorders, fixation of the eyeballs in one position, sudden unexplained death, life-threatening irregular heartbeat, heart attack, slow heartbeat, blood clots in the veins, especially in the legs (symptoms include swelling, pain, and redness of the leg), which can move through the bloodstream to the lungs, causing chest pain and breathing difficulties (if you experience any of these symptoms, you should immediately contact your doctor), high blood pressure, fainting, accidental choking on food with a risk of pneumonia, spasm of the muscles around the vocal cords, pancreatitis, difficulty swallowing, diarrhea, abdominal discomfort, abdominal pain, liver failure, hepatitis, yellowing of the skin and whites of the eyes, abnormal liver function test results, skin rash, increased sensitivity of the skin to light, hair loss, excessive sweating, severe allergic reactions, such as drug rash with eosinophilia and systemic symptoms (DRESS syndrome). Initially, DRESS syndrome resembles flu-like symptoms with a rash on the face, and then a rash appears on other parts of the body, high fever, enlarged lymph nodes, elevated liver enzyme activity (visible in blood tests), and elevated levels of a certain type of white blood cell (eosinophilia), abnormal breakdown of muscles leading to kidney function disorders, muscle pain, stiffness, involuntary urination (incontinence), difficulty urinating, withdrawal symptoms in newborns in case of exposure to the medication during pregnancy, prolonged and (or) painful erection, difficulty regulating body temperature or overheating, chest pain, swelling of the hands, ankles, or feet, abnormal blood test results: increased or changed blood sugar levels, increased glycated hemoglobin levels, inability to resist the impulse, urge, or temptation to engage in activities that may harm you or others, including behaviors such as: strong impulse to gamble excessively despite significant personal or family consequences; changed or increased interest in sex and behaviors that significantly disturb you or others, such as increased sexual drive; uncontrolled shopping; uncontrolled eating (eating large amounts of food in a short time) or compulsive eating (eating more food than usual and more than needed to satisfy hunger); tendency to wander. If you experience such behaviors, you should tell your doctor to discuss ways to control or reduce these symptoms. In elderly patients with dementia taking aripiprazole, more cases of death have been reported. Additionally, cases of stroke or "mini" stroke have been noted.

Additional Side Effects in Children and Adolescents

In adolescents aged 13 years and older, side effects occurred with a similar frequency and type as in adults. Exceptions include: drowsiness, uncontrollable trembling or sudden movements, restlessness, and fatigue, which occurred very frequently (more than 1 in 10 patients), as well as abdominal pain, dry mouth, rapid heartbeat, weight gain, increased appetite, tremors, uncontrollable movements of the limbs, and dizziness, especially when standing up from a lying or sitting position, which occurred frequently (more than 1 in 100 patients).

Reporting Side Effects

If you experience any side effects, including those not listed in this package leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medication.

5. How to Store Aripiprazole Sandoz

Keep this medication out of the sight and reach of children. Do not use this medication after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the month stated. There are no special precautions for storing this medication. Medications should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medications that are no longer needed. This will help protect the environment.

6. Package Contents and Other Information

What Aripiprazole Sandoz Contains

• The active substance of Aripiprazole Sandoz is aripiprazole. Aripiprazole Sandoz 10 mg: one orally disintegrating tablet contains 10 mg of aripiprazole. Aripiprazole Sandoz 15 mg: one orally disintegrating tablet contains 15 mg of aripiprazole. Aripiprazole Sandoz 30 mg: one orally disintegrating tablet contains 30 mg of aripiprazole.
• Other ingredients are: 10 mg and 30 mg tablets: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, aspartame (E951), magnesium stearate, red iron oxide (E172), vanilla flavor (containing maltodextrin, arabic gum, propylene glycol, benzyl alcohol, vanilla flavors). 15 mg tablets: lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal anhydrous silica, aspartame (E951), magnesium stearate, yellow iron oxide (E172), vanilla flavor (containing maltodextrin, arabic gum, propylene glycol, benzyl alcohol, vanilla flavors). See section 2: "Aripiprazole Sandoz contains lactose, sodium, aspartame, and benzyl alcohol".

What Aripiprazole Sandoz Looks Like and Contents of the Package

10 mg tablets are round, flat, pink, 8.0 mm ± 0.1 mm in diameter, with "10" printed on one side and smooth on the other side. 15 mg tablets are round, flat, yellow, 9.0 mm ± 0.1 mm in diameter, with "15" printed on one side and smooth on the other side. 30 mg tablets are round, flat, pink, 10.0 mm ± 0.1 mm in diameter, with "30" printed on one side and smooth on the other side. Aripiprazole Sandoz 10 mg and 15 mg Orally disintegrating tablets are packaged in peelable blisters perforated paper/PET/Aluminum/PVC/Aluminum/OPA and placed in a cardboard box. Package sizes: Perforated blisters: 14 x 1, 28 x 1, 30 x 1, 56 x 1, 98 x 1 orally disintegrating tablets. Aripiprazole Sandoz 30 mg Orally disintegrating tablets are packaged in peelable blisters perforated paper/PET/Aluminum/PVC/Aluminum/OPA and placed in a cardboard box. Package sizes: Perforated blisters: 28 x 1, 30 x 1, 56 x 1, 98 x 1 orally disintegrating tablets.

Marketing Authorization Holder

Sandoz GmbH Biochemiestrasse 10 6250 Kundl, Austria

Manufacturer

Rontis Hellas Medical and Pharmaceutical Products S.A. P.O. Box 3012 Larisa Industrial Area 41004 Larisa, Greece Genepharm S.A. 18th km Marathonos Ave 15351 Pallini Attiki, Greece Salutas Pharma GmbH Otto-von-Guericke-Allee 1 39179 Barleben, Germany Lek Pharmaceuticals d.d. Verovškova 57 1526 Ljubljana, Slovenia

For More Information on This Medication and Its Names in the Member States of the European Economic Area, Please Contact:

Sandoz Polska Sp. z o.o. ul. Domaniewska 50 C 02-672 Warsaw tel. 22 209 70 00 Date of Last Revision of the Package Leaflet:10/2021 Sandoz Logo